Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 1:20 PM
NCT ID:
NCT01966159
Description:
None
Frequency Threshold:
5
Time Frame:
12 month
Study:
NCT01966159
Study Brief:
The EVOLVE China Clinical Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SYNERGY Investigational Device (Test) | SYNERGY Investigational Device (Test): percutaneous coronary intervention | None | None | 38 | 205 | 66 | 205 | View |
| PROMUS Element Plus Investigational Device (Control) | PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention | None | None | 27 | 207 | 60 | 207 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| coronary artery dissection | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| atriventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| intracardiac thrombus | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| ventricular arthythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| coronary artery thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| gastrooesophageeal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| colonic polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| lung neoplasm maligant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| sudden hearing loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| plague shift | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| blood glucose icreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.0) | View |
| glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| nephrotic syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| aortic intramural haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| mycardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |